Pellet coating processes are usually driven by fairly well optimized procedures, while coating suspension sprayed on pellets and adverse effects, such as agglomeration, cannot be seen during coating process and are only detected at the very end of the process, when it is too late for any adjustments of the coating process. The aim of this study is to evaluate digital visual imaging as process analytical technology (PAT) tool for fluid-bed pellet coating processes. The method accurately estimates spherical diameter, coating thickness and adverse agglomeration of pellets by contactless measurements, classification and analysis of pellets based on digital imaging. The obtained results indicated that the method is feasible for real-time controlling, understanding, designing and optimizing of fluid-bed pellet coating processes according to PAT guidance.
COBISS.SI-ID: 7904340
A systemic approach to development of process analytical technology (PAT) tools for monitoring the critical quality and performance attributes of the manufacturing process is of great importance in ensuring final product quality in the pharmaceutical industry. The aim of this study was to examine the possibilities for a visual inspection technique as a PAT tool for in-process and on-line monitoring of the coating process of pharmaceutical pellets. The in-process conditions of the Wurster coating system were studied and an experimental visual imaging system that mimics these conditions was set up. Image analysis methods were developed that allow the determination of pellets' coating thickness estimation from the images acquired during the coating process. The results of the proposed visual imaging method were evaluated through comparison with a reference method and a good agreement of the coating thickness estimations by the two methods was found.
COBISS.SI-ID: 8830804